MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The aquabeam robotic system's log file was reviewed, which confirmed no malfunctions related to the reported event.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for lot number 19c00568 was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications when released for distribution.A review for similar complaints was performed on lot number 19c00568, which confirmed that there was one (1) other similar event reported on this lot.The aquabeam robotic system's instructions for use, ifu320301, was reviewed and "bleeding" is listed as potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this event.A root cause for the reported event could not be determined.Bleeding is an anticipated perioperative risk of the aquablation procedure.Based on the review of the log file, dhr, and ifu the event is considered not to be device related.

Event Description

Male patient underwent an aquablation procedure.As part of the aquablation procedure, spot cautery around the bladder neck was performed followed by a foley balloon catheter insertion.The foley balloon catheter color was light pink when the patient was taken out of the operating room (or).During post-operative recovery the hospital staff released traction on the foley balloon catheter and then the catheter color changed to red (per manufacturer's instructions for use, bleeding is a potential risk post-aquablation procedure).The physician reported that the patient's hemoglobin levels decreased from approximately 12 g/dl pre-procedure to 8 g/dl in the recovery room; therefore the patient received 800 ml of blood transfusion.No other clinical sequela was reported with the patient.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, CA 94065-1494 ; 6502327291
• MDR Report Key: 9433770
• MDR Text Key: 185722410
• Report Number: 3012977056-2019-00062
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Device Lot Number: 19C00568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention